Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

Evaluation of Perioperative Core Body Temperature When Using Forced Air Warming or BARRIER® EasyWarm to Prevent Inadvertent Perioperative Hypothermia: An Open-label, Randomized Non-inferiority Comparison

This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively.

A non-inferiority, prospective, open-labelled, randomized, parallel investigation.

Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia.

The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups.

A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.

Study Overview

• Status: Completed
• Conditions: Inadvertent Perioperative Hypothermia; Preoperative Anxiety Experienced by the Patient
• Intervention / Treatment: Device: Active self warming blanket; Device: Forced air warming device

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35043
    • Universitätsklinikum Gießen und Marburg GmbH
• Norway
  • Oslo, Norway, 0424
    • Ullevål - Oslo Universitetssykehus
• United Kingdom
  • Sheffield, United Kingdom, S10 2SB
    • Royal Hallamshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
• Male and female subjects aged 18 years and over
• Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
• Scheduled surgery must be performed entirely under general anaesthesia
• The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
• The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting
• The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia

Exclusion Criteria:

• Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
• Known Diabetes with an HbA1c of more than 6 %

• Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:

  1. The subject's normal temperature regulation or
  2. Perception of external temperature or
  3. Subcutaneous lipoatrophy

• Current use of concomitant medications that present relevant risk to/of:

  1. The subject's normal temperature regulation or
  2. Perception of external temperature or
  3. Subcutaneous lipoatrophy
• Epidural/Spinal anaesthesia
• An oral temperature measurement ≥ 37.5°
• Contraindications to the oesophagus temperature probe and oral thermometer
• Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
• Pregnancy
• Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active self-warming blanket; Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase	Device: Active self warming blanket; BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.; Other Names: BARRIER® EasyWarm
ACTIVE_COMPARATOR: Forced air warming device; Active warming with forced air warming (FAW) during the intraoperative phase.	Device: Forced air warming device; Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.; Other Names: Bair Hugger™; Equator® level 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Difference in Core Body Temperature in the Two Treatment Groups.	Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.	Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Alexander Torossian, Prof. MD, Universitätsklinikum Gießen und Marburg GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Patient warming; Active warming; Forced Air Warming; Warming blanket
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: MD13-001